2 Coronavirus vaccine moves to final testing stageExBulletin

AILSA CHANG, Host:

The two companies today announced that they have begun extensive testing of potential coronavirus vaccines. The first is a collaboration between the National Institutes of Health and US biotechnology company Moderna. The other is a collaboration between pharmaceutical giant Pfizer and German biotechnology company BioNTech. Each trial requires 30,000 volunteers. And here’s Joe Palca, NPR Science Correspondent, to tell us more.

Hey, Joe.

JOE PALCA, BYLINE: Hello, Ailsa.

CHANG: Yes, two vaccines, not one, are moving into this new major pilot phase. How should these vaccines work?

PALCA: Well, they really-it’s interesting. Both of them are called mRNA vaccines. It’s a new approach to making a vaccine, injecting a small piece of RNA into someone. And it prompts their cells to make proteins. And that protein stimulates the immune system and can repel it if exposed to coronaviruses. However, this is an entirely new technology as there are no FDA approved mRNA vaccines yet.

Chan: Yes. Now that these vaccines have been tested this month, what’s the difference with this latest testing phase?

PALCA: Well, the earliest stage of testing is to make sure that the vaccine does not cause the horrifying side effects that patients or people feel completely intolerable. And they went through that hurdle. There are also tests to see if an immune response occurs, but this is a laboratory test. Can the evidence actually prevent people from getting infected when exposed to the coronavirus? And it requires so many people because they have to give people a reasonable opportunity to be exposed so they can tell if the vaccine is better than placebo because they are divided in half. That’s why. Some get a vaccine. Some get placebo.

Chan: Yes. I’ve heard well that it usually takes several years to create new vaccines, but these vaccines apparently seem to be on a much faster timeline. How did that become possible?

PALCA: Well, all the manufacturers and government officials working on this are saying, look. I’m doing something different now. Instead of doing things one by one-serial; 1-first phase 1, then phase 2, then phase 3 and wait for each phase to complete-if you have a chance, reduce the time to get ready Everything is ready because you can. I hope this works. And if so, you can move forward. However, when announcing the launch of the NIH and Moderna vaccine trial, Francisco Linds, director of the National Institutes of Health, said at a conference call this morning that the trial was part of Operation Warpspeed. And the warp speed suggests that it’s really very fast. But…

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FRANCIS COLLINS: Nothing has been done here to jeopardize the safety of this particular study or others, nor does it compromise the final conclusions about whether the vaccine is effective.

Palka: Some people have suggested that it means we’re getting closer to the answer, but if you’re uncertain in October, the White House claims it’s effective and politicizes it. I admit it as a coup just before the election. But they’re saying-scientists are saying, no, we don’t make it happen.

Chan: So how do you know if these vaccines really work?

Palka: Well, that would take time. As I said, there are two groups. Vaccine group and placebo group. And even if you don’t know what your participants are getting, you will have a group that keeps an eye on the results. And they are called data safety monitoring boards. Their first task is to prevent the vaccine from making people sick. But they are also watching if there is a difference between the number of sick people who get the vaccine (preferably none) and the sick people who get only placebo. So within a few months, the answer may be available.

Chan: All right. That’s NPR Science correspondent Joe Parka.

Thank you, Joe.

Palka: You’re welcome.

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